Bimini Technologies LLC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Suction, Lipoplasty (MUU) (6) Instrument, Manual, Surgical, General Use (MDM) (3) Platelet And Plasma Separator For Bone Graft Handling (ORG) (1)

Premarket Exempt

No Yes

Clear

Combined Adapter - 00850034511016 Catalog Number :

Device Description : The Puregraft Combined Adapter is an autoclavable, reusable medical device used

Device Class : 1

Duns Number: 076649467

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Puregraft Instrument Set - 00850034511030 Catalog Number :

Device Description : Is composed of the Puregraft Easel and Puregraft Slider. Both components are mad

Device Class : 1

Duns Number: 076649467

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Puregraft Vacuum Lid - 00850034511054 Catalog Number :

Device Description : This device fits onto the Medela 3000cc Vacuum Canister, an off-the-shelf medica

Device Class : 1

Duns Number: 076649467

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Puregraft 50 System - 00850034511108 Catalog Number :

Device Description : A sterile, single use, closed polyolefin bag contains two polyester meshes and b

Device Class : 2

Duns Number: 076649467

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

Puregraft 250 System - 00850034511139 Catalog Number :

Device Description : A sterile, single use, closed polyolefin bag contains two polyester meshes and b

Device Class : 2

Duns Number: 076649467

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

Puregraft 250 System - 00850034511177 Catalog Number :

Device Description : A sterile, single use, closed polyolefin bag contains two polyester meshes and b

Device Class :

Duns Number: 076649467

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

Puregraft 850 System - 00850034511191 Catalog Number :

Device Description : A sterile, single use, closed polyolefin bag contains two polyester meshes and b

Device Class : 2

Duns Number: 076649467

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

Dermapose Refresh - 00850034511252 Catalog Number :

Device Description : A sterile, single use microsizing syringe system intended for the harvesting, co

Device Class : 2

Duns Number: 076649467

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

Adaptive - 00850034511269 Catalog Number :

Device Description : A sterile, single use, syringe assembly that is intended for separating and conc

Device Class : 2

Duns Number: 076649467

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

AutoPose Restore - 00850034511276 Catalog Number :

Device Description : A sterile, single use microsizing syringe system intended for the harvesting, co

Device Class : 2

Duns Number: 076649467

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

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